Any News on a Vaccine Yet?

indigo girl · Jun 23, 2009

http://chealth.canoe.ca/channel_health_news_details.asp?news_id=28342&news_channel_id=145&channel_id=145

You may want to consider the pneumovax also although it appears that viral rather than bacterial pneumonia is more frequently being seen in the hospitalized cases.

Here is a recent article on vaccines from one of the very best science reporters, Canadian, Helen Branswell. It appears that this is going to be a joint effort of vaccine manufacturers as well as the NIH (NIAID) in the US, and possibly other agencies in which each will be looking at different aspects of the research that needs to be done to assure the safety of these proposed vaccines. It sounds like a hugh undertaking, and it cannot be rushed.

Making vaccine and convincing regulatory agencies that the stuff is safe to inject into humans are separate matters. That is always the case but is especially true when the vaccine in question is to protect against swine flu.
The last time mass vaccination against a swine flu virus was undertaken, a spike in cases of Guillain Barre syndrome among those vaccinated led U.S. authorities to abandon the program.
It is still not known why that 1976 vaccine seemed to trigger an elevated number of cases of the paralyzing condition. (The syndrome, which is linked to several natural infections and to some vaccines, generally reverses itself over time.)
There are lots of questions regulators like Health Canada or the U.S. Food and Drug Administration will want answered before they give the go-ahead to pandemic H1N1 vaccines. And the clinical trials needed to get those answers take time.
"We can't hasten the time frame that you need to do clinical trials to get the fundamental, basic information that you generally need," says Dr. Tony Fauci, head of the U.S. National Institute for Allergy and Infectious Diseases.
NIAID is one of the U.S. National Institutes of Health. It will be working with the FDA and with U.S. licensed flu vaccine manufacturers to determine research needs for the new vaccine. The aim is to fill data gaps individual companies won't or can't undertake to plug.
Those include looking at vaccine safety in potentially more vulnerable groups like infants, people who are immunocompromised and pregnant women.

Another question NIAID may try to answer is whether it would be possible to compress the interval between two swine flu shots, if, as suspected, two shots are needed.
Companies will likely test a regime that would see two shots given with a 21- or 28-day interval. But if the pandemic starts to worsen and it appears waiting so long would be unwise, could the same effect be achieved with two shots given closer together? Companies probably won't do that research, but NIAID could, Fauci says.
The types of studies companies will need to do are the ones that answer the core questions about a vaccine. Is it safe to use in humans? Does it elicit an immune response - rising levels of antibodies - that would suggest it will be protective? What sized dose, and how many doses, does it take to do so?
Getting those answers means weeks of work by individual companies. They'll start by injecting their products first into animals, then into small numbers of human volunteers to determine that the vaccines are safe.
Once that is clear, larger trials will be needed to determine how large a dose people need to get a good immune response. That could take a couple of months, says an expert who has done many trials on flu vaccine.
"No matter how quickly you enrol the subjects in the study, even if everybody was enrolled on the same day, it's still going to take time to get the study done and get the data," says Dr. John Treanor, who teaches at the University of Rochester in northern New York.
That work should answer the question of whether people might get enough protection from a single shot or whether, because this is a new virus for our immune systems, two shots will be required. Experts hope for the former, but suspect the latter.
The industry has years of experience making flu shots and there is a high degree of confidence a successful swine flu vaccine can be made. But each flu virus has its own quirks and no one knows yet how well this new one will do at eliciting an immune response in people.
"Until they actually get it and start putting it into some animals and humans, they're not going to know for sure," says Halperin, a professor at Dalhousie University and principal investigator of the newly formed Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network.
Because seasonal flu shots have to be updated on a regular basis, regulatory agencies have a sort of fast-track process in place for these vaccines.
As long as nothing about the production of the vaccine changes, vaccine against a new strain or subtype of flu virus can be switched in under an existing licence with minimal additional information required.
That may not be the case here, however.
Some manufacturers - including GlaxoSmithKline, which has Canada's pandemic vaccine contract - have indicated they want to use adjuvants in their vaccines. Adjuvants are boosting chemicals that allow smaller doses to be used, which would speed up the time it takes to make enough vaccine for a country.
But there are no existing flu vaccines in Canada that contain adjuvants, so adding one could require an entirely new licence - and substantially more safety data based on clinical trials.
It is believed Canada will purchase adjuvanted vaccine. But what testing it will require to assure itself of the product's safety isn't currently known.

(hat tip Avian Flu Diary)

indigo girl · Jun 24, 2009

HHS Announces Advanced Development Contract for New Way to Make Flu Vaccine

http://www.hhs.gov/news/press/2009pres/06/20090623c.html

This is the new cell based technology, said to be faster than using eggs. They are going to be using insect cells. I feel somewhat better about that than I did about the use of monkey cells although the thought of any of this stuff makes me feel squeamish.

I try not to think too much about it. Bug cells, yuck...

The good news is that this is going to be another vaccine plant on US soil. The bad news is that it's not here yet. We will be waiting in line for vaccine behind the citizens of the manufacturer's host country if we have to import vaccine.

HHS Secretary Kathleen Sebelius announced today that the department will pursue advanced development of new way to make influenza vaccine. The work will be done by Protein Sciences Corporation, Inc., of Meriden, Conn., under a new $35 million contract. The contract could be extended up to five years at a total cost of approximately $147 million.
"The technology has advanced in recent years to a point that we believe it could help meet a surge in demand for U.S.-based vaccine for seasonal and pandemic flu," Secretary Sebelius said. "We want to use the technology to help our nation respond to emerging infectious diseases."
With this new technology, known as recombinant influenza vaccine, a gene would be extracted from a flu virus and placed into an insect virus called baculovirus, which does not affect people and can multiply quickly to high levels in insect cells. The cells are purified to become a basic part of a human vaccine.
Using this method, vaccine candidates, clinical investigational lots, and commercial-scale vaccine production may be available faster than by using traditional vaccine production methods. Because the basic cells can be frozen and stored indefinitely, manufacturing large quantities of a vaccine is also faster using this recombinant technology.
If this new technology is demonstrated to be safe and effective and the FDA licenses the new technology for flu vaccines, the contract requires the company to establish domestic manufacturing capability to provide a finished vaccine within 12 weeks of pandemic onset and to produce at least 50 million doses of pandemic flu vaccine within six months of pandemic onset.

indigo girl · Jun 24, 2009

Protein Sciences, Connecticut vaccine maker, forced to bankruptcy

http://www.rep-am.com/articles/2009/06/22/business/421347.txt

So much for the good news...

Creditors of Protein Sciences Corp., which started making a vaccine to protect humans against the H1N1 influenza virus last week, filed a petition to force the company into bankruptcy to be liquidated to satisfy claims.
Creditors filed an involuntary Chapter 7 petition against the Meriden-based company listing claims of $11.7 million, according to court documents filed Monday in U.S. Bankruptcy Court in Wilmington, Del.
There have been more than 40,000 confirmed cases of the H1N1 virus, commonly known as "swine flu," and 180 deaths confirmed worldwide, according to data compiled by Bloomberg News. The World Health Organization raised its alert on the virus to level six, the highest level, declaring the first influenza pandemic since 1968.
Protein Sciences said in a June 15 statement it started manufacturing "the first and only" vaccine, PanBlok, that would be able to combat the virus, for the next few months. The closely held company said it would be able to produce at least 100,000 doses of the vaccine a week.
The company uses so-called recombinant DNA technology to produce its vaccines, rather than using viruses grown in an egg to create a vaccine as most pharmaceutical companies do.
Last May, Emergent BioSolutions Inc. agreed to acquire "substantially all of the assets" of Protein Sciences after the company was granted "fast-track" status by the Food and Drug Administration for its FluBlok vaccine, according to a statement. As part of the deal, Emergent would pay $28 million in cash and take on Protein Science's debt, a 5-year note worth $20 million that could be converted to Emergent stock at a price of $12.50 a share, and as much $30 million more if FluBlok sales met certain milestones.
A unit of Emergent holds a bulk of the debt listed on the petition at $11.5 million.

indigo girl · Jun 26, 2009

Large-scale H1N1 vaccine production begins at Sanofi-Pasteur

http://www.reuters.com/article/rbssHealthcareNews/idUSN2529731620090625?rpc=401&

French drug maker Sanofi-Aventis (SASY.PA) has begun large-scale production of a vaccine for the H1N1 swine flu at its facilities in the United States and France, the company said on Thursday.
Production of the vaccine for the new flu virus, which has caused a global pandemic, will use conventional egg-based vaccine technology, the company said in a statement. The statement did not specify how many doses of the swine flu vaccine the company is making.
Sanofi, which makes vaccines through its Sanofi-Pasteur unit, said dosage requirements for the vaccine will be based on clinical trials expected to take place during the summer in the northern hemisphere.
The announcement came as the company addressed a meeting of the Advisory Committee on Immunization Practices, which advises the U.S. Centers for Disease Control and Prevention.
Sanofi, which has said it makes 40 percent of the world's supply of flu vaccine, said it is continuing to make seasonal influenza vaccine for the 2009/2010 northern hemisphere flu season, as recommended by the U.N. World Health Organization.
Production of seasonal flu vaccine for both northern and southern hemispheres is still a priority, the company said.
Seasonal influenza causes an estimated 250,000 to 500,000 deaths per year worldwide.
Sanofi has said that at full capacity, its two Pennsylvania factories can make 150 million doses of seasonal influenza vaccine a year. Its French plant can make 120 million doses per year, according to Sanofi.

indigo girl · Jun 26, 2009

Canada Moves Toward Swine Flu Vaccinations

http://news.therecord.com/article/559775

It would be smart to concentrate on those at the highest risk first particularly with the first available batches of vaccine. Seniors so far appear to be at the least risk.

The decision about whether to undertake a mass vaccination of Canadians against H1N1 flu has been all but taken, the country's chief public health officer said yesterday. Dr. David Butler-Jones said given the behaviour of the new H1N1 virus and the risk it poses, there is little chance Canada wouldn't push ahead with a vaccination program in the fall. "At this point I cannot imagine not immunizing, given the nature of this disease, its variability and its risk to people, both in terms of illness but also serious illness and death,'' Butler-Jones said in an interview with The Canadian Press.
A number of countries have placed orders with flu vaccine manufacturers for H1N1 flu vaccine, which will take several months to produce. But some -- like the United States, where memories of the 1976 H1N1 flu incident are still strong -- have said they may delay making a decision about whether to use the vaccine until closer to the time when products have been tested and approved by regulatory agencies.
Canada was the first country in the world to sign a pandemic flu vaccine contract. In 2001 it entered into a 10-year agreement with Shire Biologics -- later bought by ID Biomedical, which was later bought by vaccine giant GlaxoSmithKline -- that required the manufacturer to be constantly ready to begin production of enough vaccine to protect every Canadian who wants to be vaccinated.
The contract guarantees Canada access to the first vaccine that will be produced at GSK's manufacturing facility in Ste-Foy, Que.
Having domestic capacity to produce pandemic vaccine has long been considered a key to ensuring access. Pandemic planners have recognized that if a pandemic began to cause severe disease and a crisis situation arose, countries with vaccine manufacturing facilities within their borders might refuse to allow vaccine to be exported until domestic needs had been met.
Butler-Jones said there are decisions still to be made, including whether the country ought to offer the vaccine to everyone and in what order groups like children, adults and seniors should be vaccinated.

This article has been reformatted.

indigo girl · Jun 26, 2009

Swine Flu’s Multi-Shot Vaccine May Overwhelm State-Run Clinics

http://www.bloomberg.com/apps/news?pid=20601202&sid=a52Uaa6UqHsA#

So if they are saying two shots for swine flu, that means, this is the non adjuvant vaccine.

The vaccine being developed to combat a pandemic of swine flu will require multiple shots to provide immunity from the new virus and the added immunizations may overwhelm U.S. state agencies, health officials said.
Two injections will be required three weeks apart for swine flu, also known as H1N1, and a third will be needed for seasonal flu, health officials said at a meeting today at the U.S. Centers for Disease Control and Prevention, in Atlanta. Children younger than 9 years will need four shots, the CDC said.
The U.S. government has taken the unusual step of purchasing all of the swine flu vaccine, and the shots will probably be administered through vaccine clinics set up by state health organizations, the CDC said. The agency estimates that at least 50 million vaccine doses will be available in the U.S. by October 15, and enough vaccine to immunize everyone in the country will be available later in the season.
“Public health departments are under-funded and will get fatigued,” said William Schaffner, an influenza expert at Vanderbilt University School of Medicine in Nashville, Tennessee, in an interview at the flu conference. “One shot probably gives you very little immunity, 10 to 20 percent at most.”

indigo girl · Jul 10, 2009

U.S. government to pay for flu vaccine campaign

http://www.boston.com/news/science/articles/2009/07/09/us_government_to_pay_for_flu_vaccine_campaign/

The U.S. government will pay for any vaccination program against the H1N1 swine flu, and may encourage schools to help vaccinate children, Health and Human Services Secretary Kathleen Sebelius said on Thursday.
Sebelius said plans were on track for a mid-October vaccination program, and she urged states and territories to get plans in place now. It will likely run alongside the annual seasonal flu vaccine campaign and may include schools and other non-traditional sites as vaccination centers.
"At mid-October we might have as much as 100 million doses of vaccine," HHS vaccine expert Dr. Bruce Gellin told the meeting.
Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said clinical trials would likely begin in August to make sure the new H1N1 vaccines are safe, and to see which dose will be best. "All of this seems to be pretty much on schedule but when you are dealing with vaccines, anything can happen," Fauci said in an interview.
"We have a little bit more than a month ... to get our acts together," Dr. Anne Schuchat of the U.S. Centers for Disease Control and Prevention said at the meeting.
Federal advisers plan a July 29 meeting to discuss who should get vaccinated. Companies making an H1N1 vaccine include Sanofi-Aventis, Novartis AG, Baxter International Inc, GlaxoSmithKline, Solvay and nasal spray maker MedImmune, part of AstraZeneca.

VickyRN, MSN, DNP, RN · Jul 10, 2009

Thank you for this information, Indigo :)

indigo girl · Jul 13, 2009

Swine flu vaccine production hits a snag

http://www.google.com/hostednews/canadianpress/article/ALeqM5hJMZ2o0rf1lyVv_1ZIxwdlZOqJuQ

Will we have a vaccine ready by the fall? Maybe not...

Swine flu vaccine production has hit a snag, with manufacturers reporting a disappointingly low yield when vaccines viruses are grown in eggs. The World Health Organization says so far the yield for egg-based production is half or less what manufacturers get when they make vaccine to protect against seasonal H1N1 viruses. The lion's share of influenza vaccine is made by companies that grow the viruses in eggs.
New seed strains are being made in the hopes of increasing the vaccine yield, a report by the WHO's vaccine chief, Dr. Marie-Paule Kieny says. But if the yield cannot be increased, it will slow the rate at which pandemic vaccine comes out of the production pipeline, adding to the time it takes to protect populations in countries like Canada that have purchased vaccine. And countries that haven't pre-ordered pandemic vaccine would face substantial delays before manufacturers have product to sell to them.
Kieny's presentation calls the yield "less than optimal" and says laboratories in the WHO's lab network are generating new sets of vaccine viruses as quickly as possible. Her presentation illustrates the impact low yield would have on availability of vaccine.
Somewhere between 850-900 million and 1.8 billion doses of pandemic vaccine are already spoken for, she reports. The low end of the scale represents what would be needed by countries with contracts if it is shown that one shot will be enough to protect a person; the high end represents what those countries would need if two shots per person are required.
If all manufacturers used the lowest possible effective dose, if yields are on a par with seasonal H1N1 production and if countries only used one dose per person, manufacturers could fill all their advantage purchase orders by mid-November, Kieny's presentation suggests.
That best-case scenario also requires that all manufacturing capacity remains devoted to pandemic vaccine and no portion shifts back to the production of seasonal vaccine for next year's Southern Hemisphere flu season.
If companies don't use low doses and countries that have pre-purchased vaccine demand two shots for all their citizens, it could be mid-April before the vaccine manufacturers in high-income countries have free capacity to devote to making vaccine for middle-and-low income countries, Kieny's presentation estimates.
Ninety per cent of the world's flu vaccine production capacity is in the high-income countries that use seasonal flu vaccine.
A lower yielding vaccine "would considerably push back the timelines," the presentation warns.
Assuming the yield is half that of seasonal flu vaccine production, it would be mid-January before producers could fill all contracts if they use a single-shot, low-dose regime, Kieny estimates.
She suggests even with low-dose shots, a low-yield scenario would mean manufacturers would not be able to fill all their existing contracts until next June if the countries opt for two shots per person for all their citizens.

Reformatted.

(hat tip Avian Flu Diary)

indigo girl · Jul 13, 2009

http://www.flutrackers.com/forum/showpost.php?p=265382&postcount=1

I could have linked to the WHO document but the flutracker's version is easier to read. These recommendations just came out today, July 13. The prioritization is slightly different from the US, I think. Very noticeable is that the elderly are to be the very last group immunized. These guidelines are very good, imo. The bulk of fatalities occur in pregnant women and those aged 15 to 49, and WHO says they should be immunized before healthy kids. Health care workers should be immunized first to care for everybody else.

All countries should immunize their health-care workers as a first priority to protect the essential health infrastructure.
SAGE suggested the following groups for consideration, noting that countries need to determine their order of priority based on country-specific conditions:
pregnant women;
those aged above 6 months with one of several chronic medical conditions;
healthy young adults of 15 to 49 years of age;
healthy children;
healthy adults of 50 to 64 years of age; and
healthy adults of 65 years of age and above.
Since new technologies are involved in the production of some pandemic vaccines, which have not yet been extensively evaluated for their safety in certain population groups, it is very important to implement post-marketing surveillance of the highest possible quality. In addition, rapid sharing of the results of immunogenicity and post-marketing safety and effectiveness studies among the international community will be essential for allowing countries to make necessary adjustments to their vaccination policies.
In view of the anticipated limited vaccine availability at global level and the potential need to protect against "drifted" strains of virus, SAGE recommended that promoting production and use of vaccines such as those that are formulated with oil-in-water adjuvants and live attenuated influenza vaccines was important.

indigo girl · Jul 13, 2009

don't hold your breath waiting for the shot

http://www.scottmcpherson.net/journal/2009/7/13/dont-hold-your-breath-or-create-false-hope-waiting-for-that.html

here is a commentary from scott mcpherson, the chief information officer [cio] of the florida house of representatives on the vaccine dilemna.

i never knew that the 1976 swine flu vaccine was used the following year in another flu outbreak, did you? scott loves to ladle out these little surprising facts.

the who has just declared that it does not see a mass-produced swine flu vaccine until next year at the earliest. first, the whole news story. then, my usually concise and brilliant commentary.
who: no licensed swine flu vaccine til end of year
by maria cheng – 4 hours ago
london (ap) — a fully licensed swine flu vaccine might not be available until the end of the year, a top official at the world health organization said monday, in a report that could affect many countries' vaccination plans.
but countries could use emergency provisions to get the vaccines out quicker if they decide their populations need them, marie-paule kieny, director of who's initiative for vaccine research, said during a news conference.
the swine flu viruses currently being used to develop a vaccine aren't producing enough of the ingredient needed for the vaccine, and who has asked its laboratory network to produce a new set of viruses as soon as possible.
so far, the swine flu viruses being used are only producing about half as much "yield" to make vaccines as regular flu viruses.
the public health community may still be scarred by the u.s.' disastrous 1976 swine flu vaccination campaign, which was abruptly stopped after hundreds of people reported developing guillain-barre syndrome, a paralyzing disorder, after getting the flu vaccine. (bold mine)
several drugmakers are currently considering using adjuvants, ingredients used to stretch a vaccine's active ingredient, which could allow for many more vaccine doses. but little or no data exists on the safety of vaccines with adjuvants in populations including children and pregnant women. and in the u.s., there are no licensed flu vaccines that use adjuvants.
copyright © 2009 the associated press. all rights reserved.
i bolded the reference to 1976 because it is relevant. in 1976, several people contracted guillain-barre syndrome and died. as a result, the vaccine was pulled from production. and yet, when a/victoria broke out in early 1977 at a nursing home in miami, the only vaccine available was the bivalent swine flu shot. they broke it out and never saw a statistically significant rise in guillain-barre, even though it was the same vaccine! why has never been determined.
the first doses of swine flu vaccine that rolls off anyone's assembly line will be directed at first responders and medical personnel. doctors, nurses, police and fire and ems/emts will be the first to get the shots. so will national guard troops, i suspect. then will come the high-risk groups, beginning with anyone from age 5 to 50. then will also concurrently come persons with high risk factors, such as hiv, lupus, diabetes, cancer patients on chemotherapy, persons with other auto-immune disorders, persons with copd, and so on.
and as of today, it is highly doubtful if any of these shots will come before the first of the year. with the pandemic's first wave still underway and its second wave forecast for autumn, that means we will be well into the second wave before any vaccine hits the masses.
so don't pin your hopes on a vaccine that might not come until the pandemic's second wave has returned. focus on the things you know work and share those things with others. eventually, there will be a vaccine. but do what needs to be done until (and during and after) that time.